DEVICE: ROM Plus®, Fetal Membranes Rupture Test (00814247020406)

Device Identifier (DI) Information

ROM Plus®, Fetal Membranes Rupture Test
ROM-1025
In Commercial Distribution

CLINICAL INNOVATIONS, LLC
00814247020406
GS1

1
809524291 *Terms of Use
ROM Plus® Easy Strip Complete Kit Fetal Membranes Rupture Test
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
42923 Amniotic fluid leak detection device IVD
An in vitro diagnostic device designed to help identify amniotic fluid in the vaginal secretions of a pregnant woman to confirm membrane rupture (normal or premature). The device typically involves a colour indicator that signals within the pH range of amniotic fluid (above 6.5) after contact. The device may consist of a panty liner with attached indicator strip, or a nitrazine-impregnated swab or paper. The device may be used in the home or in a clinical setting. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NQM Immunoassay For Detection Of Amniotic Fluid Protein(S).
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K110605 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 4 and 24 Degrees Celsius
Special Storage Condition, Specify: Store in a dry place. Do not freeze
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

99f21712-c235-416e-bc22-0059560a86d2
November 19, 2020
4
September 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10814247020403 25 00814247020406 In Commercial Distribution
20814247020400 4 10814247020403 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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